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Health product recall

DCA Systems Hemoglobin A1C Kit (January 31, 2013)

Starting date:
January 31, 2013
Posting date:
February 18, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-23307

Reason

Siemens has received complaints regarding barcode scanning issues with the DCA Hemoglobin A1C cartridges. Internal investigations have confirmed that cartridge barcode integrity issues are causing unsuccessful scans and preventing testing on the DCA Systems. This issue has been isolated to two lots of DCA HBA1C kits.

Affected products

DCA Systems Hemoglobin A1C Kit (2013-01-31)

Lot or serial number

0618102, 0619102

Model or catalog number

5035C

Companies

Manufacturer
Siemens Healthcare Diagnostics Inc.